Regulatory UpdatesSep 12, 2026•1 min read

FDA Approves PROCHLORPERAZINE EDISYLATE Injection (ANDA212257)

By the PharmaCountry team

The FDA has approved the ANDA212257 application for PROCHLORPERAZINE EDISYLATE injectable, manufactured by Somerset Therapeutics, for intramuscular and intravenous use.

The U.S. Food and Drug Administration has granted approval for the Abbreviated New Drug Application (ANDA) number 212257 for PROCHLORPERAZINE EDISYLATE. The product, marketed by Somerset Therapeutics, LLC, is an injectable formulation available for intramuscular and intravenous administration. The original submission received an approved status on September 13, 2024, and a labeling supplement was approved on June 1, 2026. The drug is classified as a prescription human medication, with the generic and brand names both listed as PROCHLORPERAZINE EDISYLATE. It is supplied under NDC codes 70069-371-01 and 70069-371-25.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#Prochlorperazine #ANDA #FDA #injection #Somerset Therapeutics